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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146363
Other study ID # 17801
Secondary ID 2019-002932-10J2
Status Completed
Phase Phase 3
First received
Last updated
Start date September 24, 2019
Est. completion date May 3, 2022

Study information

Verified date November 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 424
Est. completion date May 3, 2022
Est. primary completion date June 21, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Male or female adults and adolescents (=12 years and =40 kg) - Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit - Eczema Area and Severity Index (EASI) score =16 at the baseline visit - Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit - =10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit - History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable Exclusion Criteria: - Prior treatment with dupilumab or tralokinumab - Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit - Treatment with any of the following agents within 4 weeks prior to the baseline visit: - Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.) - Phototherapy and photochemotherapy (PUVA) for AD - Treatment with the following prior to the baseline visit: - An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer - Cell-depleting biologics, including to rituximab, within 6 months of baseline - Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer - Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study - Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma - Evidence of active acute or chronic hepatitis - History of human immunodeficiency virus (HIV) infection or positive HIV serology - History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin - Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Lebrikizumab
Subcutaneous injection
Other:
Placebo
Subcutaneous Injection

Locations

Country Name City State
Australia The Skin Centre Benowa Queensland
Australia Eastern Clinical Research Unit Box Hill Victoria
Australia Emeritus Research Camberwell Victoria
Australia Skin Health Institute Inc. Carlton Victoria
Australia Sinclair Dermatology East Melbourne Victoria
Australia Fremantle Dermatology Fremantle Western Australia
Australia The St. George Hospital Kogarah New South Wales
Australia Holdsworth House Medical Practice Sydney New South Wales
Australia Burswood Dermatology Victoria Park Western Australia
Australia Skin & Cancer Foundation Australia Westmead New South Wales
Australia Veracity Clinical Research Pty Ltd Woolloongabba Queensland
Canada CCA Medical Research Ajax Ontario
Canada Skin Health Cobourg Ontario
Canada Dermatology and Dermatologic Surgery Ottawa Ontario
Canada CARe Clinic Red Deer Alberta
Canada The Centre for Dermatology Richmond Hill Ontario
Estonia Kliiniliste uuringute Keskus OU Tartu
France CHU de Bordeaux Hopital Saint Andre Bordeaux Cedex
France CHU DIJON - Hopital le Bocage Dijon Cedex
France Cabinet Médical Martigues
France Hopital Saint-Louis Paris Cedex 10
France Hopital Larrey Toulouse cedex 9
Korea, Republic of Korea University Ansan Hospital Ansan-si Gyeonggi-do
Korea, Republic of Incheon St. Mary's Hospital Incheon
Korea, Republic of Pusan National University Hospital Pusan Korea
Korea, Republic of Chungang University Hospital Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Hanyang University Medical Center Seoul Korea
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Soon Chun Hyang University Seoul Hospital Seoul Yongsan-gu
Korea, Republic of Ajou University Hospital Suwon-si Kyung Gi-Do, Korea
Korea, Republic of Ulsan University Hospital Ulsan Korea
Latvia Clinic of Dermatology and STD Riga
Latvia Health and Aesthetics LTD Riga
Latvia Health Center 4, Affiliate Diagnostic Center Riga
Latvia Latvian Dermatology Institute Riga
Latvia Smite Aija - Practice in Dermatology Venereology Talsi
Lithuania Hospital of Lithuanian University of Health Sciences Kauno klinikos Kaunas
Lithuania JSC "CD8 Alergology Clinic" Kaunas
Lithuania Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos Vilnius
Lithuania Inlita (Santaros CTC) Vilnius
Lithuania JSC "Center for Diagnosis and Treatment of Allergic Diseases" Vilnius
Lithuania Jsc Renmeda Vilnius
Lithuania Vilnius University Hospital Santaros klinikos Vilnius
Poland Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o. Iwonicz Zdroj Wojewodztwo Podkarpackie
Poland Centrum Medyczne Angelius Provita Katowice Slaskie
Poland GynCentrum Sp z o.o. Katowice
Poland Diamond Clinic Krakow Malopolskie
Poland Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME Krakow
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 Lublin
Poland Centrum Alergologii Teresa Hofman Poznan
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin West Pomeranian
Poland Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O. Tarnow Malopolska
Poland Centralny Szpital Kliniczny MSWiA Warszawa Mazowieckie
Poland Clinical Research Group Sp. z o.o. Warszawa
Poland CityClinic Przychodnia Lekarsko-Psychologiczna Wroclaw
Spain Hospital General Universitario Alicante Alicante
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital Infanta Leonor Madrid
Spain Sant Joan de Deu Serveis En Salut Mental SANT BOI DE Llobrega Barcelona
Spain Hospital Universitario Virgen Macarena Sevilla
United States Bellaire Dermatology Bellaire Texas
United States Wallace Medical Group, Inc. Beverly Hills California
United States St. Francis Medical Institute Clearwater Florida
United States IACT Health - VHC Columbus Georgia
United States Central Connecticut Dermatology Cromwell Connecticut
United States Henry Ford Hospital Detroit Michigan
United States California Dermatology & Clinical Research Institute Encinitas California
United States Johnson Dermatology Fort Smith Arkansas
United States Belle Aimee Skincare Clinic Fountain Valley California
United States Clinical Partners, LLC Johnston Rhode Island
United States JDR Dermatology Research Las Vegas Nevada
United States Dermatology Research Associates Los Angeles California
United States Skin Sciences, PLLC Louisville Kentucky
United States Clinical Research Institute Medford Oregon
United States Community Research Foundation Inc Miami Florida
United States Icahn Sch of Med at Mt. Sinai New York New York
United States Sadick Research Group New York New York
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Oregon Medical Research Center Portland Oregon
United States ALLCUTIS Research Portsmouth New Hampshire
United States Beacon Clinical Research, LLC Quincy Massachusetts
United States Wake Research Associates Raleigh North Carolina
United States MediSearch Clinical Trials Saint Joseph Missouri
United States St Joseph Dermatology and Vein Clinic Saint Joseph Michigan
United States Progressive Clinical Research San Antonio Texas
United States ACRC Studies San Diego California
United States Premier Clinical Research Spokane Washington
United States ForCare Clinical Research Tampa Florida
United States Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Dermira, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Estonia,  France,  Korea, Republic of,  Latvia,  Lithuania,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Baseline to Week 16
Primary Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (=75% Reduction in EASI Score) From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a = 75% improvement from baseline in the EASI score.
Baseline to Week 16
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 2 The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Baseline to Week 2
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 4 The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Baseline to Week 4
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 in Adults The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Baseline to Week 16
Secondary Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a = 90% improvement from baseline in the EASI score.
Baseline to Week 16
Secondary Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =4-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =5-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 16
Secondary Percent Change in EASI Score From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in Percent Body Surface Area (BSA) at Week 16 The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. Baseline, Week 16
Secondary Percentage of Participants Achieving EASI-90 From Baseline to Week 4 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a = 90% improvement from baseline in the EASI score.
Baseline to Week 4
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Secondary Percentage of Participants Achieving =4 Point Improvement in DLQI From Baseline to Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. Baseline to Week 16
Secondary Percentage of Participants With a DLQI Total Score of =4-point at Baseline Achieving =4-point Improvement in DLQI From Baseline to Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. Baseline to Week 16
Secondary Percent Change in Sleep-loss Score From Baseline to Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. Baseline, Week 16
Secondary Change From Baseline in Sleep-loss Score at Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. Baseline, Week 16
Secondary Percentage of Participants With a Sleep-loss Score =2 Points at Baseline Who Achieve a =2 Points Reduction From Baseline at Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. Baseline to Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 1
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 2
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 4
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 1
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 2
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 4
Secondary Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Mean was calculated using the ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Secondary Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52 PK: Average serum concentration of lebrikizumab at the Week 52 trough timepoint. Serum concentration is a combined measure obtained from Baseline, Week 4, Week 16, Week 32, Week 52 and average measure was reported at week 52. Predose: Baseline, Week 4, Week 16, Week 32, Week 52
Secondary Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a = 75% improvement from baseline in the EASI score.
Baseline to Week 52
Secondary Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a =2-point Improvement From Baseline at Week 16 Who Continue to Exhibit and IGA 0 or 1 and a =2-point Improvement From Baseline at Week 52 The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Baseline to Week 52
Secondary Percentage of Participants From Those With a Pruritus NRS of =4-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 52
Secondary Percentage of Participants From Those With a Pruritus NRS of =5-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 52
Secondary Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52 The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS mean was calculated using ANCOVA model with treatment group, baseline value, and stratification factors geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 52
Secondary Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.
LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS) The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1# 2 days = 1; 3-4 days = 2; 5#6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed. Baseline, Week 16
Secondary Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents PROMISĀ® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Depression at Week 16 - Adolescents PROMISĀ® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater depression. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Anxiety at Week 16 - Adults PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Depression at Week 16 - Adults PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater depression. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control.
LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).
LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
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